Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.

Condition or disease

Intervention/treatment

Sternal Wound InfectionSternal Non-unionPainMediastinitis

Device: SternaLock Rigid Fixation PlatesDevice: wire (control)

Detailed Description:

Median sternotomy patients will be randomized to either wire or rigid fixation groups. A scheduled evaluation period will record clinical parameters. Enrollment has ended with one hundred forty (140) patients.

Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an "Activity Based Total Visual Analog Pain Score", (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.